Medtronic’s Micra Transcatheter Pacing System — the world’s smallest pacemaker — has won CE Mark approval, the Dublin, Ireland, devicemaker announced Tuesday.
The Micra TPS is the size of a large vitamin or less than one-tenth the size of most pacemakers, the company says.
Implanted directly into the heart through minimally invasive catheter delivery, the device does not require leads, removing a potential source of complications.
The device works by attaching to the heart wall and reacting to patient activity levels by automatically adjusting therapy. Its battery life is estimated at 10 years and is approved for full body MRI scans, the devicemaker added.
Medtronic is conducting a single-arm, multicenter clinical trial. It will eventually enroll up to 780 patients at an estimated 50 centers across 20 countries. The European Commission granted CE Mark approval based on three-month study results from the first 60 patients. The trial’s initial results will be revealed in May.
The Micra TPS is classified as an investigational device in the U.S. and is not approved for commercial sale.
Pacemaker therapy is the most common treatment for a slow heartbeat. One million pacemakers are implanted every year. — Jason Scott